BIOFREEDOM STEMI REGISTRY

Brief summary:

BioFreedom Stemi Registry is a prospective, multicenter, fully observational post market registry designed to enroll 1000 STEMI patients at 15 centers in 7 Asian countries where the BioFreedom™ BA9™ (SS) DCS is available for clinical use. All enrolled patients will be followed up for 1 year.

Primary endpoints

Target Lesion Failure (TLF) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC2 definitions)

CERC Asia Services

• Project Management
• Site Start-up
• Regulatory Submissions
• Contracts and payments Management
• Monitoring
• Safety Annual Reporting
• Organization of CEC

CERC Services :

• • • Data Management/EDC
    • Corelab (Events)

 

Countries

Hong Kong, Malaysia, Singapore, South Korea, Taiwan, Thailand, Vietnam

Center number : 15 centers + 2 satellite sites